Merck KGaA Darmstadt Germany - Dover, DE
posted about 2 months ago
The Associate Clinical Research Manager (aCRM) for Infectious Disease at Merck is a pivotal role that involves comprehensive project management and oversight of clinical trials within a designated country. This position is responsible for ensuring that all assigned protocols are executed in compliance with ICH/GCP guidelines, local regulations, and company policies. The aCRM serves as the main point of contact for assigned protocols, acting as a crucial link between Country Operations and the Clinical Trial Team (CTT). This role requires a proactive approach to planning, driving, and tracking the execution of deliverables, timelines, and results to meet country commitments from the feasibility stage through to site selection, recruitment, execution, and closeout of studies. In this role, the aCRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements. Responsibilities include reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The aCRM leads local study teams, providing training on protocols and collaborating closely with Clinical Research Associates (CRAs) and other local roles to ensure high performance and effective coordination of activities. Additionally, the aCRM is responsible for creating and executing local risk management plans and ensuring compliance with key systems such as CTMS and eTMF. The position also involves building and maintaining strong business relationships with investigators and external partners, supporting local and regional strategy development, and collaborating with various internal functions to align on key issues and decisions across trials. The aCRM must possess strong organizational skills, scientific knowledge, and the ability to communicate effectively in a remote environment, making strategic decisions and managing multiple deliverables simultaneously.